MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-07 for VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK 6801042 manufactured by Ortho-clinical Diagnostics.
[128276828]
The investigation concluded that a lower than expected vitros myoglobin (myog) quality control (qc) result was obtained using a non-vitros (biorad) qc fluid in combination with a vitros 5600 integrated system. A definitive assignable cause of the event could not be determined. Historical qc results for vitros myog lot 1321 were reviewed and were acceptable with respect to accuracy and precision. However, ortho has become aware of a calibrator stability issue post reconstitution and this issue is being investigated. There was also no indication of an instrument malfunction and unexpected instrument performance is not a likely contributor to the event. However, the customer did not perform a within run precision test when requested at the time of the event to definitively rule out an instrument issue. A definitive assignable cause of the event could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[128276829]
A customer obtained a lower than expected vitros myoglobin (myog) quality control (qc) result using a non-vitros (biorad) qc fluid in combination with a vitros 5600 integrated system. Vitros myog result of 57. 902 ng/ml versus the package insert mean of 68. 17 ng/ml. Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. The lower than expected vitros myog result was generated from a non-patient fluid, however the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. Ortho has not been made aware of allegation of actual patient harm as a result of the event. This report corresponds to ortho clinical diagnostics inc (ortho). Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2018-00168 |
| MDR Report Key | 8045583 |
| Date Received | 2018-11-07 |
| Date of Report | 2018-12-17 |
| Date of Event | 2018-09-23 |
| Date Mfgr Received | 2018-10-10 |
| Device Manufacturer Date | 2018-03-09 |
| Date Added to Maude | 2018-11-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAMES A STEVENS |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal | 14626 |
| Manufacturer Phone | 5854533000 |
| Manufacturer G1 | ORTHO CLINICAL DIAGNOSTICS |
| Manufacturer Street | FELINDRE MEADOWS PENCOED |
| Manufacturer City | BRIDGEND, WALES CF355PZ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF35 5PZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | DDR |
| Date Received | 2018-11-07 |
| Catalog Number | 6801042 |
| Lot Number | 1321 |
| Device Expiration Date | 2019-02-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-07 |